CHAPTER II

COMPOSITIONAL REQUIREMENTS
SECTION 2

General requirements, restrictions and specifications

General requirement on substances
Article 8
Substances used in the manufacture of plastic layers in plastic materials and articles shall be of a technical quality and a purity suitable for the intended and foreseeable use of the materials or articles. The composition shall be known to the manufacturer of the substance and made available to the competent authorities on request.

Specific requirements on substances
Article 9
1
Substances used in the manufacture of plastic layers in plastic materials and articles shall be subject to the following restrictions and specifications:
a
the specific migration limit set out in Article 11;
b
the overall migration limit set out in Article 12;
c
the restrictions and specifications set out in column 10 of Table 1 of point 1 of Annex I;
d
the detailed specifications set out in point 4 of Annex I.
2
Substances in nanoform shall only be used if explicitly authorised and mentioned in the specifications in Annex I.

General restrictions on plastic materials and articles
Article 10
General restrictions related to plastic materials and articles are laid down in Annex II.

Specific migration limits
Article 11
1
Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. Those specific migration limits (SML) are expressed in mg of substance per kg of food (mg/kg).
2
For substances for which no specific migration limit or other restrictions are provided in Annex I, a generic specific migration limit of 60 mg/kg shall apply.
3
By derogation from paragraphs 1 and 2, additives which are also authorised as food additives by Regulation (EC) No 1333/2008 or as flavourings by Regulation (EC) No 1334/2008 shall not migrate into foods in quantities having a technical effect in the final foods and shall not:
a
exceed the restrictions provided for in Regulation (EC) No 1333/2008 or in Regulation (EC) No 1334/2008 or in Annex I to this Regulation for foods for which their use is authorised as food additive or flavouring substances; or
b
exceed the restrictions set out in Annex I to this Regulation in foods for which their use is not authorised as food additive or flavouring substances.

Overall migration limit
Article 12
1
Plastic materials and articles shall not transfer their constituents to food simulants in quantities exceeding 10 milligrams of total constituents released per dm2 of food contact surface (mg/dm2).
2
By derogation from paragraph 1, plastic materials and articles intended to be brought into contact with food intended for infants and young children, as defined by Commission Directives 2006/141/EC and 2006/125/EC , shall not transfer their constituents to food simulants in quantities exceeding 60 milligrams of total of constituents released per kg of food simulant.
OJ L 401, 30.12.2006, p. 1.
OJ L 339, 6.12.2006, p. 16.